摘要
About the Role
Major accountabilities:
- Co-ordinate UK RA publishing operations to ensure effective management of workload within the UK RA Compliance Team
- Drive the development and implementation of end-to-end best practice relating to country publishing activities to ensure the efficient transmission of technically high-quality submissions are consistently made to UK HA
- Support onboarding and act as mentor of UK Regulatory Publishing and Compliance Associates
- UK Regulatory Information Management (RIM) Subject Matter Expert, ensuring UK data compliance in the global RIM system
- Actively representing UK RA in the Global RA Process Improvement and Excellence Network
- Support the preparation and involvement of UK RA in internal global audits and external inspections, including CAPA management
- Support project management and implementation of pan-portfolio regulatory initiatives to ensure efficient and compliant outcome to ensure business continuity
- Support Regulatory Compliance and Process Lead to address potential quality issues and emerging compliance concerns and recommend solutions, providing backup support, as needed with quality incidents/deviations in the appropriate system
Key performance indicators:
KPIs as identified during annual objective setting
Minimum Requirements:
Life Science Degree or equivalent in education and experience
Work Experience:
- Dependent on individual aptitude, but would expect a minimum of 2-3 years’ experience of a broad range of regulatory work in the ethical pharmaceutical industry
Skills:
Knowledge of operational aspects of regulatory affairs
Compliance and Quality mind-set
Ability to be innovative and a creative problem solver with quality and compliance approach.
Excellent communication and interpersonal skills
Languages :
- English.
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